Onboarding
We review your products, PV system and existing documentation.
Qualified persons responsible for pharmacovigilance, provided as a service: EU QPPV, UK QPPV and country-level LPPV.
Marketing authorisation holders in the EU must have a Qualified Person Responsible for Pharmacovigilance (QPPV) permanently and continuously at their disposal, as described in GVP Module I. Many other countries also require a local qualified person or contact person.
With URAS PV's EU QPPV, UK QPPV and country-based LPPV services, these legal obligations are assumed by experienced professionals, including back-up arrangements and documented oversight of your pharmacovigilance system.
We review your products, PV system and existing documentation.
The QPPV or LPPV is appointed and notified to the relevant authorities.
Ongoing oversight of safety data, compliance metrics and PV system changes.
We build global PV systems fully compliant with international standards (ICH, GVP) and act as local LPPV representatives in 15+ countries.
Global and local pharmacovigilance detailsFull-scope support for creating, maintaining, and keeping the Pharmacovigilance System Master File (PSMF) inspection-ready at all times.
PSMF writing and management detailsWriting and review of pharmacovigilance SOPs and working instructions aligned with GVP and local requirements.
SOP writing detailsCollection, assessment, coding (MedDRA), and electronic submission of Individual Case Safety Reports (ICSR) to systems such as EudraVigilance and FDA FAERS.
ICSR processing detailsProactive signal detection, benefit-risk analysis, and the preparation of periodic safety reports (PBRER / DSUR).
Signal management detailsContinuous monitoring of global and local literature (PubMed + local journals), case identification, and reporting.
Literature monitoring detailsOur validated safety database unifies ICSR management, coding, and regulatory submissions on a single platform.
Safety database detailsPV audit preparation, internal audit services, and regulatory training programmes for your teams.
Audit and training detailsAn overview of our end-to-end pharmacovigilance services.
All pharmacovigilance servicesTalk to our team and let us design a tailored solution for you.
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